(36 days)
A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
Nitrile Powder Free Patient Examination Gloves
I am sorry, but the provided document is a 510(k) clearance letter for "Nitrile Powder Free Patient Examination Gloves" and an "Indication For Use Statement." It does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device's AI component. It is a regulatory document confirming the substantial equivalence of gloves to a predicate device. Therefore, I cannot extract the requested information from this document.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.